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Coverage and Correct Coding of YONDELIS®

Joint DME MAC Publication

On 10/23/2015 the FDA gave accelerated approval to YONDELIS® (trabectedin), a chemotherapy treatment for specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

The DME MACs have evaluated YONDELIS® and determined that it is not eligible for inclusion in the DME External Infusion Pumps (L33794).

Claims to the DME MACs for YONDELIS® whose administration is initiated in a provider’s office will be rejected as wrong jurisdiction. Please consult with the appropriate A/B MAC for potential reimbursement under part B of the Medicare Program.

Please refer to the external infusion pump LCD and related policy article for additional coverage, coding and documentation requirements.

For questions about correct coding, contact the PDAC at 877-735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or email the PDAC by completing the DME PDAC Contact Form.

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